Job Title: Senior Product Development Engineer
Waukegan, IL, US, 60087-1826
Description: Develops micro interconnect and micro cable assembly medical device products. Leads product development activities and reports progress to management. Specific duties include:
- Review and assign workloads of Engineering Technicians based on a per-project basis
- Lead continuous improvement teams and recommend improvements to manufacturing processes
- Serve as technical leader on project teams and delegate tasks to team members
- Manage project costs, including goods-sold analysis and monitor project spending and budgets
- Design, develop and implement manufacturing fixtures for medical device products
- Generate statistical analysis of quality; perform gage repeatability and reproducibility; determine defects; and introduce subsequent improvements to development process for medical devices
- Work closely with strategic customers, sales, application engineers, engineering technicians and manufacturing staff to design, develop, and introduce new medical device technologies and products to market and report progress to management. Provide support to sales team by performing cost and capacity estimates
- Develop manufacturing instructions, test methods and procedures, master validation plan, and protocols required for FDA and regulatory submission for medical devices
- Develop manufacturing process fit for clean-room environment and FDA standards
- Perform root-cause analysis and implement corrective and preventive actions. Perform Process Failure Mode and Effects Analysis
- Generate and execute engineering change notices for medical devices
Requirements: Master’s degree/equivalent in Biomedical Engineering and 5 years’ related experience; or bachelor’s degree and 8 years, including: 3 years’ medical device manufacturing to ISO 13485 standard; and 2 years’ theory of constraints, Lean/Six Sigma methodologies, project management, Aras PLM or other PLM systems, supervising technicians, design/develop laser processing and value added to medical device components, planning and executing product validation, coordinating and executing projects in offshore facilities, SolidWorks, AutoCAD and/or Creo, and risk management tools, such as FMEA. 25% international and domestic travel.